SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN

Brief summary (registry, in English)

The purpose of this single-arm interventional study is to evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system in subjects treated with renal denervation. Additionally, long-term follow-up data will also be collected from eligible subjects previously treated in the SPYRAL PIVOTAL-SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED studies.

What you commit to

• Study type: Interventional
• Participants enrolled: 1899
• From 20 Oct 2021 to the primary completion date, 5 Mar 2026
• 97 sites in 11 countries
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (97)

Sites in registry order. Save your city in your profile to sort them by distance.

Related publications

• Effectiveness of Radiofrequency Renal Denervation in the United States: Six-Month Primary End Point Results From the SPYRAL AFFIRM Study.Circ Cardiovasc Interv · 2026 · PMID 42976254